510(k) Report

Devices descending from P950002

1,681 later devices reach Bak Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K190488ProLift Expandable SystemLife Spine, Inc.201916—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+5K183064TxTi IBF SystemInnovasis, Inc.2019481
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K182608Oyster ACIF CageSilony Medical GmbH20190—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+5K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K162206Zavation IBFZavation, LLC201724—
+5K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K162587Roccia® AcifSilony Medical GmbH20171—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K153400ProLift Expandable SystemLife Spine, Inc.201672—
+5K151939COALITION SpacersGlobus Medical, Inc.2016152—
+5K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+5K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc.20150—
+5K152304Tritanium PL CageStryker20154481
+5K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+5K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—